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Continuous Monitoring on the General Ward

24. april 2017 oppdatert av: Radboud University Medical Center

Continuous Monitoring of Vital Signs in Hospitalized Patients

Rationale: Monitoring patients' vital signs is done to detect clinical deterioration. For this, the MEWS, a scoring list comprising seven vital signs measured by nursing staff, is used. Although the MEWS provides relevant data on patients' health status, the interval measurements may not capture early deterioration of vital signs, especially during the night. As a result, unsafe situations may occur such as periods of low oxygen saturation and cardiac arrhythmias, which are known to complicate postoperative course. Besides, this way of measuring vital signs may be stressful for patients and disturbs patients' sleep. New technology such as ViSi Mobile and HealthPatch allows for remote continuous monitoring of vital signs using wearable devices transmitting relevant data to nurses and clinicians. With this, the investigators think that clinical deterioration may be detected in an early phase and reduce nurse work load and patient distress.

Objective: to investigate the feasibility of wearable devices on the general ward.

Study design: feasibility study.

Study population: adult patients hospitalized on the internal medicine ward and adult postoperative patients on the surgical ward.

Intervention: patients in the intervention groups will be randomized in one of the two groups. Patients in the group 1 will wear ViSi Mobile; patients in group 2 will wear the HealthPatch. Wearable devices will be worn for at least three days. Regular MEWS measurements take place at usual time points.

Main study parameters/endpoints: Evaluation with patient and care givers (primary outcome measure), MEWS calculations, time between alarm (continuous data) and next regular MEWS measurement (nurse), intervention by nurse after alarm, admission to ICU, complications, side effects of devices, STAI scores, and PCS scores will be documented.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will wear one device for at least three days. Devices can be uncomfortable by being heavy or the patches can start itching. More measurements by nurses can take place when indicated, for example after alarms. The participating patients will fill out the STAI on daily basis and the PCS on the last day of hospitalization. Both questionnaires will take a few minutes to complete. Patients could benefit from early detection of clinical deterioration and early corrective interventions or ICU admissions.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

90

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 85 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patient is 18 years or older on the day the informed consent will be signed.
  • Patient is hospitalized on the surgical or internal medicine ward.
  • MEWS measurements are required at least three times a day.
  • Patient is able to speak, read and understand the local language of the investigational site, is familiar with the procedures of the study, and agrees to participate in the study program by giving oral and written informed consent prior to screening evaluations.

Exclusion Criteria:

  • Frequency of MEWS measurements is less than three times a day.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Control group
Patients with regular measurements by nurses only (Modified Early Warning Score (MEWS))
Eksperimentell: HealthPatch (Intervention)
Patients with HealthPatch and regular MEWS measurements
The HealthPatch (Vital Connect) is a wireless patch and continuously measures single-lead ECG, heart rate, respiratory rate, stress, skin temperature, body posture and steps
Eksperimentell: ViSi Mobile (Intervention)
Patients with ViSi Mobile and regular MEWS measurements
ViSi Mobile (Sotera Wireless) is wireless device that is able to continuously measure all important vital parameters: ECG, heart rate, oxygen saturation, blood pressure, respiratory rate and skin temperature.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Expectations & experiences of patients
Tidsramme: 2-3 days after informed consent
Interviews of 15-20 minutes with patients after 2-3 days wearing a device or control group
2-3 days after informed consent
Expectations & experiences of care givers
Tidsramme: 1 year
Interviews with nurses of 15-20 minutes at the end of the study. Estimated amount of 6 nurses
1 year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
MEWS scores based on continuous data and data measured by nurses
Tidsramme: 3 times a day, up to three days.
3 times a day, up to three days.
Amount of alarms by HealthPatch or ViSi Mobile
Tidsramme: during 2-3 days when the patient wears a device
during 2-3 days when the patient wears a device
Time between alarm (continuous data) and next regular MEWS measurement (nurse)
Tidsramme: during 2-3 days when the patient wears a device
during 2-3 days when the patient wears a device
Amount of extra MEWS measurements by nurses due to alarms
Tidsramme: during 2-3 days when the patient wears a device
during 2-3 days when the patient wears a device
Admission to ICU (yes/no)
Tidsramme: during 2-3 days when the patient participates in this study
during 2-3 days when the patient participates in this study
Duration of ICU hospitalization in days
Tidsramme: during 2-3 days when the patient participates in this study
during 2-3 days when the patient participates in this study
Complications caused by disease or surgical procedure
Tidsramme: during 2-3 days when the patient participates in this study
during 2-3 days when the patient participates in this study
Adverse events caused by devices
Tidsramme: during 2-3 days when the patient wears a device
E.g. Itch or redness
during 2-3 days when the patient wears a device
Technical failures of devices (artifacts: a period longer than 1 minute the device does not measure vital parameters)
Tidsramme: during 2-3 days when the patient wears a device
during 2-3 days when the patient wears a device
Outcomes of the State Trait Anxiety Inventory (STAI)
Tidsramme: Once a day during the 2-3 days the patient participantes in this study
Once a day during the 2-3 days the patient participantes in this study
Outcomes of the Pain Catastrophizing Scale (PCS)
Tidsramme: On day 2 or 3 when patients participates in the study
On day 2 or 3 when patients participates in the study
System usability Scale
Tidsramme: 1 year
1 year

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Gender
Tidsramme: On day 1 when patients participates in the study
Extraction from EHR
On day 1 when patients participates in the study
Age
Tidsramme: On day 1 when patients participates in the study
Extraction from EHR
On day 1 when patients participates in the study
Diagnosis
Tidsramme: On day 1 when patients participates in the study
Extraction from EHR
On day 1 when patients participates in the study
Performed surgical procedure
Tidsramme: On day 1 when patients participates in the study
Extraction from EHR
On day 1 when patients participates in the study

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Harry van Goor, MD, PhD, FRCS, Radboud University Medical Center

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. april 2015

Primær fullføring (Faktiske)

1. august 2016

Studiet fullført (Faktiske)

1. september 2016

Datoer for studieregistrering

Først innsendt

25. juli 2016

Først innsendt som oppfylte QC-kriteriene

13. oktober 2016

Først lagt ut (Anslag)

14. oktober 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. april 2017

Sist bekreftet

1. juli 2016

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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